BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 14276999 · Received May 4, 2022

    Report

    Report Number
    9612164-2022-01647
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Date of Event
    December 20, 2021
    Report Date
    May 3, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; THE PREDICTIVE VALUE OF ELLIPTICAL NECK PARAMETERS AND OVERSIZING RATIO FOR TYPE IA ENDOLEAKS AFTER ENDOVASCULAR ANEURYSM REPAIR QING ET AL, J VASC INTERV RADIOL 2022; 33:375¿383 HTTPS://DOI.ORG/10.1016/J.JVIR.2021.12.020. PT INFO: MEAN AGE, MEAN GENDER, EXACT DATE OF IMPLANT UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ENDURANT STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS ON UNKNOWN DATES. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: TYPE IA ENDOLEAKS. THE CAUSE OF THE TYPE IA ENDOLEAKS ARE UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2001945 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male